JP2014532528A - Guide mechanism for implantable medical leads - Google Patents

Abstract

An implantable cardiac rhythm management (CRM) system is provided by the present invention for directing stimulation energy toward a target tissue to provide appropriate stimulation and away from unwanted tissue. The implantable cardiac rhythm management (CRM) system includes an implantable lead. The implantable lead includes a lead body and an electrically insulating member. The lead body includes at least one electrode that extends substantially around the lead body. The electrically insulating member defines at least one window. The at least one insulating member includes a protrusion configured to bring the at least one electrode closer to the target tissue.

Description

  The present invention relates to medical devices, and more particularly, the invention relates to implantable medical leads.

  An implantable medical lead is a device that delivers electrical stimulation from an implantable device to a target location within the body. Exemplary implantable devices include a cardiac rhythm management (CRM) system (eg, pacemaker, defibrillator, and cardiac resynchronization therapy device), and a neural stimulation system (eg, spinal cord stimulation (SCS)). spinal cord stimulation (AMT) system and autonomic modulation therapy (AMT) system). In a CRM system, an implantable lead is typically routed through a blood vessel to an implantation location in the patient's heart, and in a neural stimulation system, such a lead is typically neck or It is placed in the limbs, chest, spinal epidural space, or muscle. Implantable leads can also be used to stimulate autonomic nervous system (ANS) that regulates involuntary body functions, such as heart rate, digestion, and respiratory rate. ANS regulates autonomic balance, which affects various cardiac functions including heart rate, heart rhythm, contractility, remodeling, inflammation, and blood pressure. Accurate placement of the implantable medical lead in the body is important to ensure that the lead delivers electrical stimulation to the target tissue without undue stimulation of other nearby tissue.

  The objective of this invention is providing the implantable medical lead which improved the above-mentioned implantable medical lead.

  In Example 1, an implantable medical lead for stimulating or detecting a target tissue and minimizing stimulation of surrounding tissue includes a lead body that is proximal. And at least one electrode extending circumferentially around at least a portion of the lead body. An insulating sheath is disposed over at least a portion of the distal end of the lead body, the insulating sheath is configured to rotate about the lead body and electrically connects at least one electrode to the target tissue. Having an exposure window adapted to be exposed. At least one protrusion extends radially outward from a portion of the insulating sheath at a position generally opposite the exposure window, the protrusion being at least one when the insulating sheath rotates around the lead body. One electrode is adapted to be close to the target tissue so that the distance between the at least one electrode and the target tissue is shorter than the corresponding distance between the at least one electrode and the surrounding tissue.

  Example 2 is the implantable medical lead of Example 1 wherein the protrusion is molded integrally with the insulating sheath. In Example 3, the insulating sheath includes an inner insulating member and an outer insulating member having a compartment, and the protrusion is disposed on the inner insulating member and extends at least partially through the compartment. 1 is an implantable medical lead of Example 1 or Example 2, configured to do so. Example 4 is an implantable medical lead according to any of Examples 1 to 3, wherein rotation of the inner insulating member relative to the outer insulating member is limited by contact between the protrusion and the edge of the compartment. Is a line. In Example 5, the lead body includes a plurality of electrodes, the insulating sheath includes a plurality of protrusions, and each protrusion aligns with the position of the corresponding electrode along the length of the insulating sheath. 5 is an implantable medical lead of any of Examples 1 to 4 disposed at a position.

  Example 6 is an implantable medical device according to any of Examples 1 to 5, wherein the protrusion extends circumferentially around the insulating sheath over an angle of about 25 to about 120 degrees. Lead wire. Example 7 is any of Examples 1-6, wherein the protrusion is a separate structure coupled to the insulating sheath and is configured to be attachable during lead delivery. Implantable medical lead. Example 8 is any of Examples 1-7, wherein the protrusion is formed from an insulating material and is configured to protect surrounding tissue from electrical stimulation delivered by at least one electrode. Is an implantable medical lead. Example 9 is the implantable medical lead of any of Examples 1-8, wherein the exposure window is selected from the group consisting of a physical window and an electrically permeable window. Example 10 is the implantable medical lead of any of Examples 1-9, wherein the protrusion extends radially outward from the insulating sheath at a distance of about 1 mm to about 5 mm.

  In Example 11, an implantable medical lead for stimulating or detecting target tissue and minimizing irritation of surrounding tissue includes a lead body that is proximal. A plurality of spaced apart electrodes extending circumferentially around at least a portion of the tip and lead body. An insulating sheath is disposed over at least a portion of the tip of the lead body, the insulating sheath is configured to rotate about the lead body and targets at least one of the plurality of electrodes. Having a plurality of exposure windows adapted to be electrically exposed to tissue; A plurality of insulating protrusions extend radially outward from a portion of the insulating sheath at a position generally opposite the corresponding exposed window. This protrusion is adapted to bring the corresponding exposure window closer to the target tissue as the insulating sheath rotates around the lead body, so that the distance between the corresponding exposure window and the target tissue Shorter than the corresponding distance between the exposed window and the surrounding tissue.

  Example 12 is the implantable medical lead of Example 11 wherein each of the plurality of insulating protrusions extends circumferentially around the insulating sheath over an angle of about 25 to about 120 degrees. . Example 13 is the implantable medical lead of Example 11 or Example 12, wherein each of the exposure windows is selected from the group consisting of a physical window and an electrically permeable window. Example 14 is the implantable medical lead according to any of Examples 11 to 13, wherein the protrusion is formed integrally with the insulating sheath. Example 15 is an implantable according to any of Examples 11-13, wherein a plurality of insulating protrusions are configured to protect surrounding tissue from electrical stimulation delivered by a plurality of spaced apart electrodes. It is a medical lead wire. In Example 16, the insulating sheath includes an inner insulating member and an outer insulating member having a compartment, and the protrusion is disposed on the inner insulating member and extends at least partially through the compartment. It is an implantable medical lead in any one of Examples 11-14 configured as described above.

  In Example 17, a method of providing electrical stimulation to a target tissue and minimizing electrical stimulation of surrounding tissue includes providing a lead body, the lead body having a proximal end, a distal end, and a lead. Having at least one electrode extending circumferentially around at least a portion of the wire body; The lead wire main body has an insulating sheath disposed on at least a part of the distal end portion thereof. The insulating sheath has an exposure window adapted to electrically expose at least one electrode to the target tissue. The insulating sheath further has at least one protrusion that extends radially outward from a portion of the insulating sheath at a position generally opposite the exposure window. The protrusion is adapted to bring the at least one electrode closer to the target tissue as the insulating sheath rotates around the lead body. The method includes advancing the distal end portion of the lead wire body to dispose at least one electrode at a position near the target tissue, and rotating the insulating sheath to adjust the position of the protrusion to at least 1 The method further includes moving one electrode closer to the target tissue and away from the surrounding tissue.

  Example 18 is the method of Example 17, further comprising stimulating the target tissue with at least one electrode. Example 19 is the method of Example 17 or Example 18, further comprising attaching the protrusion to the insulating sheath before advancing the distal end of the lead body to a location near the target tissue. Example 20 is that the target tissue is the vagus nerve, the surrounding tissue includes muscle near the vagus nerve, and the step of rotating brings at least one electrode closer to the vagus nerve and from the muscle near the vagus nerve This is the method according to any one of Example 17 to Example 19, which is kept away.

  While numerous embodiments have been disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary embodiments of the present invention. . Accordingly, the accompanying drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

1 is a schematic diagram of a cardiac rhythm management (CRM) system according to various embodiments. FIG. 1 is a schematic diagram of an autonomic modulation therapy (AMT) system according to various embodiments. FIG. 1 is a schematic illustration of a carotid sheath including the internal jugular vein, common carotid artery, and vagus nerve. FIG. 1 is a schematic illustration of a carotid sheath including the internal jugular vein, common carotid artery, and vagus nerve. FIG. 1 is a schematic illustration of an implantable lead having a sheath with an open window, according to various embodiments. FIG. 1 is a schematic illustration of an implantable lead having a sheath with an open window, according to various embodiments. FIG. FIG. 6 is a schematic illustration of an implantable lead having a sheath with an electrically permeable window, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead having a sheath with an electrically permeable window, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead having a stop member, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead having a stop member, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead with a stop member, according to various embodiments. FIG. 7 is a cross-sectional view of an implantable lead with a stop member, according to various embodiments. FIG. 6 is a perspective view of an implantable lead with a stop member, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead with a locking member, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead with a locking member, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead with a locking member, according to various embodiments. FIG. 6 is a schematic illustration of an implantable lead with a locking member, according to various embodiments. FIG. 6 is a perspective view of an implantable lead with a locking member, according to various embodiments. FIG. 7 is a cross-sectional view of an implantable lead with a locking member, according to various embodiments. FIG. 5 is a perspective view of an implantable lead having a plurality of electrically insulating members or sheaths, according to various embodiments. FIG. 5 is a perspective view of an implantable lead having a plurality of electrically insulating members or sheaths, according to various embodiments. FIG. 5 is a perspective view of an implantable lead having a plurality of electrically insulating members or sheaths, according to various embodiments. FIG. 5 is a perspective view of an implantable lead having a plurality of electrically insulating members or sheaths, according to various embodiments. FIG. 6 is a perspective view of an implantable lead according to various embodiments. FIG. 6 is a perspective view of an implantable lead according to various embodiments. FIG. 6 is a perspective view of a lead body, according to various embodiments. FIG. 6 is a perspective view of an inner surface of a portion of an electrically insulating member, according to various embodiments. FIG. 6 is a perspective view of an implantable lead according to various embodiments. 6 is a flowchart illustrating a method for delivering electrical stimulation to a tissue site, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead with a rotating sheath having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead with a rotating sheath having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead having a protruding mechanism, according to various embodiments. FIG. 6 shows a perspective view of an implantable lead having a protruding mechanism, according to various embodiments. 6 is a flowchart illustrating a method of guiding electrical stimulation to a tissue site, according to various embodiments. FIG. 6 is a perspective view of an implantable lead for stimulating tissue, according to various embodiments. FIG. 6 is a perspective view of an implantable lead for stimulating tissue, according to various embodiments. FIG. 6 is a perspective view of an implantable lead for stimulating tissue, according to various embodiments. 2 is a cross-sectional view of a portion of an implantable lead according to an embodiment of the present invention. FIG. FIG. 4 is a schematic illustration of an implantable lead having a diameter that varies along the length of the lead, according to various embodiments. FIG. 4 is a schematic illustration of an implantable lead having a diameter that varies along the length of the lead, according to various embodiments. FIG. 6 illustrates an exemplary diameter profile along the length of an implantable lead according to various embodiments. FIG. 6 illustrates an exemplary diameter profile along the length of an implantable lead according to various embodiments. FIG. 6 illustrates an exemplary diameter profile along the length of an implantable lead according to various embodiments. 6 is a flow chart illustrating a method for delivering electrical stimulation to a target tissue site and minimizing / controlling electrical stimulation to surrounding tissue.

  While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. However, it is not intended that the invention be limited to the specific embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

  FIG. 1 is a schematic diagram of an implantable cardiac rhythm management (CRM) system 10. As shown, the system 10 includes a pulse generator 12 and an implantable lead 14 that extends from a proximal portion 18 to a distal end 20. As shown in FIG. 1, the heart 16 includes a right atrium 26, a right ventricle 28, a left atrium 30, and a left ventricle 32. The heart 16 further includes an endocardium 34 that covers the myocardium 36. In some embodiments, as illustrated, a stationary helix 24 located at the distal end 20 of the lead 14 penetrates the endocardium 34 and is implanted in the myocardium 36. In some embodiments, the stationary helix 24 is electrically actuated and thus functions as a helical electrode for detection of electrical activity of the heart 16 and / or application of stimulation pulses to the right ventricle 28. In one embodiment, the CRM system 10 includes a plurality of leads 14. For example, the CRM system 10 includes a first lead 14 adapted to transmit electrical signals between the pulse generator 12 and the right ventricle 28, and the pulse generator 12 and the right atrium 26 or coronary artery (see FIG. A second lead (not shown) adapted to transmit an electrical signal to / from the device may be provided.

  FIG. 2 is a schematic diagram of a representative implantable autonomic modulation therapy (AMT) system 110. As shown in FIG. 2, the AMT system 110 includes an implantable pulse generator 112 that generates electrical stimulation pulses and a lead 14 that extends from the pulse generator 112 to a desired stimulation site. As further shown in FIG. 2, an inferior vena cava (IVC) 114 and a superior vena cava (SVC) 116 extend from the right atrium of the heart 16. The SVC 116 is connected to an inferior jugular vein (IJV) 118. An aorta 120 extends from the left atrium of the heart 16. The aorta 120 is connected to a common carotid artery (CCA) 122. IJV 118 and CCA 122 pass through a portion of the neck adjacent to each other. As shown, the vagus nerve 46 also passes through the neck at a location near the IJV 118 and CCA 122. In addition, each of these structures is located in a fibrous connective tissue known as the carotid sheath. The lead wire 14 includes a proximal end portion 18 and a distal end portion 20, and one or more electrodes 38 at or near the distal end portion 20.

  3A and 3B illustrate an exemplary anatomical location for implantation of the AMT system 110. FIG. In particular, these figures show the structures found in the neck and carotid sheath 40. FIG. 3A is a perspective view of this anatomical region, and FIG. 3B is a cross-sectional view of the carotid sheath 40. As shown, the implantable lead 14 can be routed so that the electrode 38 is positioned at or near the vagus nerve 46, CCA 122, and IJV 118 (along the surrounding muscle and other tissues). It can be placed in the sheath 40.

  4A and 4B illustrate implantable leads 14 used to deliver stimulation energy to a desired site in an implantable system, such as CRM system 10 or AMT system 110, according to various embodiments. The tip is shown. The implantable lead 14 can be implanted at various locations including, for example, the vagus nerve, peripheral nerve, spinal cord, or near the heart. As shown, the distal portion of the implantable lead 14 includes a lead body 50 and an electrical stimulation member (or sheath) 52. The lead body 50 includes one or more electrodes 38 that extend partially or substantially around the lead body 50. In some embodiments, the lead body 50 includes an array of electrodes or a plurality of electrodes. As shown in FIGS. 4A and 4B, the lead body 50 includes four such electrodes spaced about the outer periphery of the lead body along the longitudinal axis. 38. In other embodiments, other numbers of electrodes can be disposed on the lead body.

  According to various embodiments, the electrodes extend around the lead body in various radial ranges. For example, in some embodiments, at least one electrode is disposed around the lead body so as to cover a radial surface that extends completely around the lead body (ie, 360 degrees). . In other embodiments, each electrode can extend around a separate radial position (or arc) such that it extends entirely around the lead body as a whole. For example, a first electrode disposed around a lead body so as to cover a radial surface extending from 0 to 90 degrees around the lead body defined as a first radial quadrant. An electrode, a second electrode disposed around the lead wire body so as to cover a radial surface of 90 to 180 degrees around the lead wire body defined as a second radial quadrant, A third electrode disposed around the lead wire body so as to cover a radial surface of 180 to 270 degrees around the lead wire body defined as three radial quadrants; A fourth electrode may be provided disposed around the lead body so as to cover a radial surface spanning 270 to 360 degrees around the lead body defined as a radial quadrant. In these embodiments, the electrodes may each be disposed at different longitudinal positions along the lead body, or one or more of the electrodes may be at the same longitudinal position along the lead body. It may be arranged.

  In other embodiments, these electrodes may extend collectively less than full (ie, 360 degrees) around the lead body. In these embodiments, for example, the first electrode can cover 0 to 90 degrees, the second electrode can cover 90 to 180 degrees, and the third electrode can cover 0 to 90 degrees. And the fourth electrode can cover 90-180 degrees. Further, in various embodiments, the lead body can comprise more or less than four electrodes. In further embodiments, the electrodes can be stacked to extend radially around or around the surface of the lead body. For example, the first electrode can cover 0 to 90 degrees, the second electrode can cover 45 to 135 degrees, the third electrode can cover 90 to 180 degrees, and the fourth The electrode can cover 135-225 degrees. In these embodiments, additional electrodes can be added to cover additional radial positions around the lead body.

  The lead body 50 can be formed from any flexible biocompatible material suitable for forming a lead. In various embodiments, the lead body 50 is formed from a flexible electrically insulating material, such as silicone rubber or polyurethane. In various embodiments, different segments of the lead body 50 can be formed from different materials to tailor the characteristics of the lead body to the intended clinical and surgical environment. In some embodiments, the proximal and distal portions of the lead body 50 are formed from different materials that are selected to provide the desired function.

  As further shown in FIGS. 4A and 4B, the electrically insulating member or sheath 52 extends axially across the distal end portion of the lead body 50 comprising one or more electrodes 38. The insulating sheath 52 can be formed using a flexible polymeric material having sufficient dielectric properties to sufficiently isolate or insulate the electrodes 38. The insulating sheath 52 can be formed from a thin-walled tube having sufficient mechanical properties for operation. According to various embodiments, the sheath 52 is formed from any one or more of the following: silicone, polyurethane, polytetrafluoroethylene (PTFE), and ethylenetetrafluoroethylene (ETFE). In various embodiments, the sheath 52 is reinforced with, for example, braided stainless steel. In various embodiments, the electrically insulating member or sheath 52 may include a predetermined shape, such as a helical S shape, a curved shape, or any other shape.

  Insulating member 52 defines one or more windows 58. The electrically insulating member 52 is configured to translate (ie, move axially) along the longitudinal axis of the lead body, rotate around the lead body, or both translate and rotate. , Thereby, in a first defined radial position, a first portion of at least one electrode 38 is exposed through at least one window 58, and a second portion of at least one electrode 38 is Covered by the electrical insulating member 52. In this way, an operator (eg, a physician) exposes a portion of the electrode 38 that is most suitable for stimulating the desired target site (eg, the vagus nerve) while simultaneously covering other portions of the electrode 38 and others. Can prevent (or reduce) unwanted irritation of other tissues. According to some embodiments, as shown in FIG. 4A, the insulating sheath 52 comprises a plurality of windows. In some embodiments, the windows are spaced longitudinally along the sheath at the same (or substantially the same) spacing between the electrodes 38 such that each window corresponds to a particular electrode. Yes. According to other embodiments, for example, as shown in FIG. 4B, the insulating sheath 52 is one of a size and shape that matches two or more (eg, two, three, or all) electrodes. Has windows. According to some embodiments, eg, the embodiment shown in FIGS. 4A and 4B, the window is an open section where the insulating material has been removed to form a mechanical opening.

  According to other embodiments, such as the embodiment shown in FIGS. 5A and 5B, the window 58 can have a conductive or electrically permeable region formed in the material of the lead body. The electrically permeable window can be formed from any conductive polymer material including, for example, expanded polytetrafluoroethylene (ePTFE). In various embodiments, the insulating sheath 52 comprises a plurality of windows constructed from a combination of mechanical openings and conductive portions. In some embodiments, the windows are linearly disposed at the same radial position along the lead body 50 such that all windows are generally centered along the same line. In other embodiments, the windows are disposed at separate or overlapping locations along the lead body.

  6A and 6B are schematic views of the distal portion of an implantable lead 14 used in an implantable system, such as the CRM system 10 or the AMT system 110. FIG. As shown, in these embodiments, the implantable lead 14 includes a stop member 54 coupled to the lead body 50. In the illustrated embodiment, the stop member 54 is present at or near the distal end of the lead wire body 50. In various other embodiments, the stop member 54 may be present at any other location along the lead body 50. As shown, the stop member is disposed at a location along the lead body that facilitates alignment of the window (or windows) 58 and electrode (or electrodes) 38 of the insulating sheath 52. Yes. With this mechanism, for example, a user (for example, a doctor) can advance the sheath 52 forward with respect to the lead wire body 50 until the insulating sheath 52 contacts the stop member 54. When such contact occurs, the physician knows that the sheath 52 has been disposed at a longitudinal position along the lead body 50 where the window 58 is aligned (or substantially aligned) with the electrode 38.

  Several other types of stop members can be provided on the lead body, such as the stop members shown in FIGS. 7A, 7B, and 8. 7A and 7B are a perspective view and a cross-sectional view, respectively, of an implantable lead 14 having a pin or protrusion 60 configured to function as a stop member. As shown in FIG. 7A, the sheath 52 includes a groove or slot 59 sized to receive the protrusion 60. The slot 59 and the protrusion 60 can be disposed at any longitudinal position along the sheath 52 and the lead body 50. The slot 59 is selected to have a sufficient length to allow the desired range of longitudinal movement of the sheath along the lead body. As shown in FIG. 7B, the protrusion 60 is coupled to the lead body 50 and one end of the pin 60 is spaced radially outward from the lead body 50 by a distance sufficient to engage the slot 59. It extends. The portion of the pin 60 that extends outside is configured to be received in the slot and slide along the length of the slot, and the motion is either of the two ends of the slot 59 provided in the insulating member 52. Is limited. In addition, the pin 60 further prevents or prevents rotational movement of the sheath 52 about the lead body 50.

  FIG. 8 is a perspective view of the implantable lead 14 with a mechanism for controlling movement of the sheath 52 along the lead body 50. As shown, the lead wire body 50 includes a protrusion or step 54 extending radially outward from the lead wire body 50, and the sheath 52 includes a ring 62 extending inward. As shown, the step 54 is adapted to mechanically contact the ring 62 to prevent or prevent longitudinal (ie, axial) movement along the sheath lead body. . In various embodiments, the sheath 52 extends over the step 54 such that the step 54 is located within the sheath 52. The step 54 and the ring 62 are each located at the proximal end of the lead body 50 and the proximal end of the sheath 52, according to some embodiments, so that these structures stop distal movement. Acts as a tool. In other words, when the user moves the sheath 52 toward the distal end portion of the lead wire body, the movement of the sheath toward the distal end side is prevented or prevented at the position where the step 54 and the ring 62 are in contact with each other. Again, the position of step 54 can be selected to facilitate the desired alignment between the sheath window and the lead body electrode.

  FIGS. 9 and 10 show additional structures for aligning and / or securing the sheath 52 along the lead body 50 of the lead 14. As shown in FIGS. 9A and 9B, the lead body 50 includes a radially extending protrusion or protrusion 64 that fits or couples into a recess or groove 66 in the sheath 52. Is adapted to be. FIG. 9A illustrates a configuration in which the protrusion 64 is not engaged with the recess 66, and FIG. 9B illustrates a configuration in which the protrusion 64 is engaged in the recess 66. These mechanisms can be provided at any longitudinal position along the lead body 50 and sheath 52 such that any window located on the sheath 52 is aligned or substantially aligned with the electrode located along the lead body 50. Is disposed at an appropriate position to be aligned.

  10A and 10B show another embodiment in which the recess 66 is replaced with a hole 68 and the protrusion 64 is configured to engage a hole 68 provided in the sheath 52 of the lead wire 14. . FIG. 10A illustrates a configuration in which the protrusion 64 does not engage with the hole 68, and FIG. 10B illustrates a configuration in which the protrusion 64 engages with the hole 68. These mechanisms can be provided at any longitudinal position along the lead body 50 and sheath 52 such that any window located on the sheath 52 is aligned or substantially aligned with the electrode located along the lead body 50. Is disposed at an appropriate position to be aligned.

  FIGS. 11A and 11B illustrate an embodiment of an implantable lead 14 that includes a radial locking member 70. The radial lock member 70 is configured to lock the electrical insulating member 52 with respect to the lead wire body 50 at a plurality of radial positions around the lead wire body 50. In this particular embodiment, the electrically insulating member 52 further comprises an opening 68. Further, the radial lock member 70 includes a plurality of protrusions, such as protrusions 72, configured to engage the opening 68. In one locked position, only one of the protrusions 72 is in engagement with the opening 68. For example, at a first radial position, the first protrusion engages the opening 68 and the second protrusion engages the opening 68 at the second radial position. FIG. 11A illustrates a perspective view of a structure in which one of the plurality of protrusions 72 is engaged with the opening 68. FIG. 11B illustrates a cross-sectional view of the lead wire body 50 having the protrusions 72. In this illustrated embodiment, four such protrusions 72 are shown. In various other embodiments, a different number of protrusions 72 can be utilized in the lead body design. Increasing the number of protrusions 72 can increase the resolution of radial adjustment of the sheath 52 around the lead body 50, thereby optimally guiding stimulation energy from the electrodes toward the desired target tissue. Many options are given to the user. In some embodiments, the sheath 52 can also include a suture sleeve or suture groove 71 adapted to receive a suture for securing the position of the sheath 52 relative to the lead body 50. In some embodiments, the suture groove 71 is integral with the electrically insulating member 52. In other embodiments, the suture sleeve is provided as a separate member from the sheath 52.

  FIG. 12A is a perspective view of an implantable lead 14 used in an implantable system, such as the CRM system 10 or AMT system 110. In this particular embodiment, the implantable lead 14 includes a second electrically insulating member or sheath 74 in addition to the insulating member or sheath 52. Similar to the sheath 52 having one or more windows 58, the sheath 74 also defines one or more windows 78. In such an embodiment, the user can adjust both the sheath 52 and the sheath 74 to overlap the corresponding window 58 and window 78, thereby increasing the exposure options.

  12B, 12C, and 12D are perspective views showing an embodiment comprising three overlapping electrical insulating members or sheaths. FIG. 12B shows a first sheath 52 with a first window 58, FIG. 12C shows a second sheath 74 with a second window 78, and FIG. 12D shows a first sheath with a third window 80. 3 sheaths 76 are shown. As further shown, these embodiments include corresponding screws 82, 84, 86, 88 that allow adjustment of the respective sheaths 52, 74, 76 relative to one another. When assembled to form the lead 14, the sheath 74 extends axially from end to end with respect to the sheath 52. In various embodiments, the sheath 74 can extend axially relative to the sheath 52 up to a portion of the length of the sheath 52. Similarly, in some embodiments, the sheath 76 can also extend axially from end to end with respect to the sheath 74. Further, in some other embodiments, the sheath 76 can extend axially relative to the sheath 74 up to a portion of the length of the sheath 74. Although the illustrated embodiment describes the use of three sheaths 52, 74, 76, in various embodiments, the lead 14 comprises fewer or more than three sheaths.

  As shown in FIG. 12B, the first sheath 52 comprises a series of outwardly extending screws 82 that are connected to a series of inwardly extending screws 86 on the second sheath 74. Adapted to engage. These screws allow adjustment of both the longitudinal and / or rotational alignment of the first sheath 52 and the second sheath 74. As further shown, the electrically insulating member 74 includes a series of outwardly extending screws 84 that engage a series of inwardly extending screws 88 provided in the third sheath 76. Adapted to fit. This configuration allows a user (e.g., a physician) to control the relative longitudinal and rotational orientation of each sheath 52, 74, 76 so that each corresponding window 58 can be controlled. , 78, 80 can be controlled in relative orientation. According to other embodiments, the screws 82, 86 are replaced with alternative structures (eg, guide posts) that achieve simultaneously controlled axial and radial motion.

  FIG. 13 is a perspective view of an implantable lead 14 used in an implantable system, such as the CRM system 10 or AMT system 110. As shown, the electrically insulating member or sheath 52 extends axially relative to a portion of the lead body 50 and defines a generally helical window 90. The spiral window 90 includes a first spiral edge 92 and a second spiral edge 94. Although the spiral edges 92, 94 are shown as non-parallel, in other embodiments, these edges are parallel. The helical edges 92, 94 define a helical passage that forms a helical window 90. The helical window 90 is configured to expose a region of the electrode 38 that is determined by at least one of a radial position and an axial position of the electrical insulation member 52 with respect to the lead body 50. In this embodiment, a user (eg, a physician) can change the exposure of the electrode 38 of the lead body 50. In various embodiments, the sheath 52 and lead body 50 can include various stop members of the control mechanism that provide further control and adjustment to the electrode 38 of the spiral window 90.

  FIG. 14 is a perspective view of an implantable lead 14 used in an implantable system, such as the CRM system 10 or AMT system 110. As shown, the lead wire body 50 includes a series of outward projections 96 disposed in a series of grooves 98 provided on the inner surface of the sheath 52. A series of outward projections 96 are configured to engage a series of grooves 98 and assist the user in controlling radial and axial adjustments of the sheath 52 to the lead body 50. The protrusions and grooves are configured to prevent axial movement, rotational movement, or both, thereby allowing a user to adjust the axial and rotational position under control. According to various embodiments, the protrusion 96 and the groove 98 are configured as an interlocking screw that allows controlled axial and rotational adjustment.

  FIG. 15A is a perspective view of an implantable lead 14 used in an implantable system, such as the CRM system 10 or AMT system 110. In this particular embodiment, the lead body 50 includes a first threaded portion 97 from the end of the outer diameter between the proximal end 18 and the distal end 20. As shown in FIG. 15B, the sheath 52 includes a second screw portion 99 at an inner diameter at a separate position. In other embodiments, the second threaded portion 99 can be provided over the entire length of the sheath 52. As shown in FIG. 15C, the first threaded portion 97 engages with the second threaded portion 99, and at least one of radial adjustment and axial adjustment of the sheath 52 with respect to the lead wire body 50. Is configured to allow. In one embodiment, the first screw portion 97 is a male screw and the second screw portion 99 is a female screw. In various embodiments, the first threaded portion 97 is an internal thread and the second threaded portion 99 is an external thread.

  According to some embodiments, the sheath 52 can further comprise a radiopaque marker or scale 100. The radiopaque marker 100 is configured to indicate a radial and axial position of the sheath 52 with respect to at least one electrode 38. The radiopaque marker 100 facilitates adjustment of the radial and axial positions of the sheath 52 with respect to the lead body 50 to achieve the desired radial and axial positions of the sheath 52 with respect to the lead body 50. It is further configured.

  FIG. 16 is a flowchart illustrating a method 200 for delivering electrical stimulation to a tissue site using an implantable lead. The method 200 can be used with any implantable medical lead in various applications including, for example, a CRM system or an AMT system. This method allows a user (eg, a physician) to guide stimulation toward a desired tissue site (eg, vagus nerve) and minimize or prevent stimulation of an unwanted tissue site (eg, surrounding tissue). Useful to do. In various embodiments, the desired tissue can be other nerves and the undesirable tissue can be other tissues surrounding these nerves.

  Method 200 includes positioning an electrically insulating member or sheath relative to an implantable lead body that is in a first position relative to the lead body when the lead body is in a first position. At least one window is defined to expose a first portion of the at least one electrode (block 210). According to some embodiments, the lead body 50 is first advanced toward the target site, and then a sleeve or sheath 52 is placed over the lead body. According to other embodiments, the sleeve or sheath 52 is first positioned relative to the lead body 50 and then the lead body and sleeve are advanced together toward the target site. The sheath 52 is configured to selectively insulate the electrode 38 to effectively guide stimulation energy from the electrode 38 toward the target tissue and reduce or minimize stimulation of tissue near or around the target tissue. Has been.

  Once the lead is placed in the desired location near the target tissue, the user (eg, a physician) manipulates the sheath to adjust the radial orientation, longitudinal position, or both relative to the lead body and electrode. Thus, the size and shape of the exposed portion of the electrode are effectively adjusted (block 220). This adjustment can be made before or after the lead is advanced to a location near the target tissue. In embodiments where this adjustment is made after the lead has been advanced to or near the site of the target tissue, the radial and longitudinal position of the sheath is determined by the user (eg, a physician) from the sheath base. Adjustments can be made by rotating, pushing and / or pulling the ends. In embodiments that utilize more than one sheath (see, eg, FIGS. 12A-12D), the user has additional flexibility in making adjustments. In such an embodiment, the user can adjust the radial and longitudinal positions of any sheath (and thus the corresponding window) that cooperatively form the overlapping exposed windows.

  As part of this placement step, the position of the insulating member or sheath relative to the lead body can be fixed using one of the various stop members described herein (block 230). Any of the various stop members described herein can be implemented to help align and secure the radial orientation of the sheath relative to the lead body, the longitudinal position of the sheath, or both. For example, the user can advance the sheath distally until the sheath contacts the longitudinal stop so that the window (or windows) of the sheath and the corresponding electrode (or the lead body) (or Matching with multiple electrodes) is guaranteed. The user can then rotate the sheath to further guide the stimulation energy in the desired manner.

  In some embodiments, the axial and radial adjustments of the electrical insulation member 52 relative to the lead body 50 can be controlled using the first threaded portion 97 and the second threaded portion 99. The first screw portion and the second screw portion will be described with reference to FIGS. 14 and 15. The first screw portion 97 and the second screw portion 99 can move the electric insulating member 52 in the axial direction with respect to the lead wire main body 50 by the rotation of the electric insulating member 52 relative to the lead wire main body 50. As the electrical insulation member 52 rotates, the electrical insulation member 52 advances linearly along the length of the lead body 50 to expose the electrode 38 for optimal stimulation. The first screw portion 97 and the second screw portion 99 can prevent the lateral movement of the electrical insulating member 52 with respect to the lead wire main body 50. Thereby, the lead wire main body 50 and the electrical insulating member 52 can be prevented from rotating in a chronic direction and moving away from the target tissue (that is, the vagus nerve). The first threaded portion 97 and the second threaded portion 99 can expose (or shield) the variable portion of the electrode to optimize stimulation and minimize undesirable tissue irritation. .

  After the sheath is positioned and secured to the lead body, stimulation energy is delivered to the target tissue (block 240). The electrically insulating member 52 can shield the electrode 38 to guide and direct stimulation energy to the target tissue and away from other tissues. In one embodiment, the at least one window is an electrically permeable window through which stimulation can be delivered to the target tissue. In some embodiments, for example, the implanting physician monitors both desirable and undesirable stimuli during the implantation operation. Depending on the detected results, the physician can then further adjust the radial and longitudinal position of the sheath to optimize the amount of desired and undesirable stimuli.

  In various embodiments, each electrode is disposed around the lead body so as to cooperatively cover all (ie, 360 degrees) radial surfaces around the lead body. In another embodiment, the at least one electrode is around the lead body so as to cover a radial surface ranging from 0 to 90 degrees around the lead body defined as the first radial quadrant. A first electrode disposed and a lead wire body defined around the lead wire body defined as a second radial quadrant, and disposed around the lead wire body to cover a radial surface extending 90-180 degrees; A second electrode disposed around the lead body so as to cover a radial surface of 180 to 270 degrees around the lead body defined as a third radial quadrant. And a fourth electrode disposed around the lead wire body so as to cover a radial surface of 270 to 360 degrees around the lead wire body defined as a fourth radial quadrant Can be provided. In some embodiments, the individual electrodes are oriented in different radial directions and the windows are linearly aligned along the sheath so that only one electrode is aligned with the window and hence the target tissue at any position. The other electrodes are insulated by the electrical insulation member. An electrode aligned with the window can be programmed to deliver stimulation to the target tissue.

  After implantation, when an electrode programmed to deliver stimulation to the target tissue is rotated away from the target tissue, another electrode in the nearby quadrant is automatically directed to the labeled tissue. At this time, another electrode can be programmed to stimulate the target tissue. Therefore, it is not necessary to implant again and direct the other electrodes in the nearby quadrant to the target tissue.

  Accordingly, various embodiments of the present invention provide an implantable lead having an axially movable and rotatable electrical insulation member disposed on the lead body, the lead wire comprising an electrical insulation member. A stop mechanism for easy placement relative to the lead body and an adjustment mechanism for directing the electrode to the desired target tissue are provided. The implantable lead wire realizes an axial adjustment capability and a radial adjustment capability with respect to the lead body of the electrical insulation member, and further, the electrical insulation member at a position adjusted in each of the axial direction and the rotational direction. Realizes locking to the lead wire body. The electrically insulating member can shield the electrode to guide the stimulation energy to the target tissue in focus and away from other tissues. Thus, the implantable lead can ensure alignment of the window with the appropriate electrode. The implantable lead can prevent the lead body and electrical insulation member from chronically rotating and moving away from the target tissue.

  Example 21 relates to an implantable medical lead for stimulating or detecting a target tissue, the implantable medical lead being a lead body having a proximal end, a distal end, and a lead A lead body having at least one electrode extending circumferentially around at least a portion of the body and having a longitudinal axis; and at least a rotationally coupled and disposed around a portion of the lead body At least one spacer member having a center line defined along its longitudinal axis, the center line being offset from the longitudinal axis of the lead body. The at least one spacer member is configured to adjust the spacing between the at least one electrode and the target tissue during rotation of the lead body.

In Example 22, the spacer member having a non-circular cross section is the lead wire of Example 21 having a spiral cross-sectional shape.
In Example 23, the lead of Example 21 or Example 22, wherein the at least one spacer member has a non-circular cross-sectional shape.

In Example 24, the spacer member having a non-circular cross section is the lead wire of Example 23 having an oval cross-sectional shape.
In Example 25, the lead of any of Examples 21-24, wherein the spacing between the target tissue and the electrode is adjustable between about 1 mm and about 7 mm depending on the rotational position of the spacer member relative to the target tissue. Is a line.

  In Example 26, the spacer member is disposed relative to at least one electrode and includes at least one exposure window configured to expose the at least one electrode to the target tissue. It is any lead wire of Example 25.

In example 27, the lead of example 26, wherein the at least one window is selected from the group consisting of a physical window and an electrically transmissive window.
Example 28 is the lead of any of Examples 21-27, wherein the spacer member has a length of about 2 mm to about 5 mm.

  In Example 29, the spacer member is tapered along its length such that the distance between the center line of the spacer member and the outer surface of the spacer member varies along the length. The lead wire according to any one of Examples 21 to 28.

  In Example 30, at least one spacer member includes a plurality of spacer members disposed at spaced positions along the lead wire body, and at least one electrode is disposed between two of the plurality of spacer members. The lead wire according to any one of Example 21 to Example 29.

Example 31 is the lead of example 30, wherein the plurality of spacer members are of different geometric shapes.
In Example 32, each of the plurality of spacer members is the lead of Example 30 or Example 31 having a different outer diameter such that the implantable medical lead has a generally tapered shape.

  In Example 33, an implantable medical lead for stimulating or detecting a target tissue is a lead body, circumferentially around at least a portion of the proximal end, the distal end, and the lead body. A lead body including at least one electrode extending in the direction and having a first longitudinal axis; and a plurality of spacer members disposed about and rotationally coupled about a portion of the lead body, the non-circular member And a plurality of spacer members having a centerline defined along the longitudinal axis of the spacer member, the centerline being offset from the longitudinal axis of the lead body, and The spacer member is configured to adjust the spacing between the at least one electrode and the target tissue during rotation of the lead body.

  In Example 34, a method of minimizing irritation to an irrelevant tissue site and supplying electrical stimulation to a target tissue site comprising implanting an implantable lead into a patient's body, the implant A possible lead is a lead body comprising a proximal end, a tip, and at least one electrode extending circumferentially around at least a portion of the lead body and a first longitudinal axis And at least one spacer member disposed about and rotationally coupled about the distal end of the lead wire body and having a centerline defined along its longitudinal axis A spacer member, the center line comprising at least one spacer member offset from the longitudinal axis of the lead wire body by an offset distance; Rotate the line body, comprising the steps of adjusting the spacing between the at least one electrode and the target tissue site, the.

Example 35 is the method of example 34, further comprising stimulating body tissue with at least one electrode.
Example 36 is the method of example 35 further comprising detecting electrical stimulation at the target tissue site and further rotating the lead body based on the stimulation level detected at the target tissue site.

  In example 37, the method of example 36, wherein the target tissue site is the vagus nerve, whereby the rotating step includes adjusting the spacing between the vagus nerve and the at least one electrode.

Example 38 is the method of any of Examples 34 to 37, wherein the spacer member has a non-circular cross-sectional shape selected from the group consisting of an egg shape and a spiral shape.
17A and 17B include a mechanism disposed at the distal end of the lead and guides stimulation energy to the target tissue (eg, the vagus nerve) and from other surrounding tissues (eg, adjacent muscles). Fig. 3 illustrates various embodiments of an insulating member configured to be spaced away. The insulating member of FIGS. 17A and 17B can be used with any of the various implantable leads 14 described above. According to various embodiments, FIGS. 17A and 17B are used, for example, in the configurations shown in and described with reference to FIGS. 12B-12D. In these embodiments, the plurality of insulating members 5, 74, 76 can be rotated relative to each other to adjust the size of the exposure window for exposing the electrode 38. As described above, the insulating member can comprise cooperating screws 82, 86, 88 shown in FIGS. 12B-12D, for example. The male screw 82 of the electrical insulation member 52 is configured to engage with the female screw 86 of the electrical insulation member 74 to fix (hold) the electrical insulation members (eg, 52, 74, and 76) to each other. According to various embodiments, the exposure window can be a physical opening or an electrically transmissive portion.

  As shown in FIGS. 17A and 17B, the outermost insulating member or sheath 76 includes one or more protrusions 100 disposed at defined locations along the length of the insulating member. ing. The protrusion (or plurality of protrusions) 100 can be disposed at a position corresponding to one or more electrodes 38 along the lead body 50 or in the vicinity thereof, thereby enabling a user (eg, a physician) However, the position of the protrusion 100 can be adjusted to adjust the distance between the at least one electrode 38 and the first surrounding tissue adjacent to the defined portion. This technique allows the user to move the electrode 38 closer to the desired target stimulation site (eg, the vagus nerve) and / or away from unwanted adjacent tissue. For example, according to various embodiments, the physician rotates or adjusts the protrusion 100 such that the protrusion 100 is positioned adjacent to the undesirable adjacent tissue, and thus the unwanted tissue and the stimulation electrode 38. There is a gap between them or they are separated.

  According to various embodiments, the protrusion 100 can extend continuously to a defined portion of the insulating member. In other embodiments, the protrusions 100 can extend discretely to defined portions of the insulating member. In still other embodiments, the protrusion 100 can extend continuously to a defined portion. For example, a defined portion of the lead 14 can include a number of protrusions 100 disposed at discrete locations in the defined portion. According to the continuous pattern of protrusions 100, the defined portion is the length from the first side edge of the protrusion 100 to the second side edge of the protrusion 100. According to the discrete pattern including the plurality of protrusions 100, the defined portion is from the side edge of the first protrusion 100 (near the first side edge of the lead wire 14) to the side edge of the last protrusion 100. This includes the length of the outer surface of the lead wire 14 or the insulating member 76 up to the portion (near the second side surface end portion of the lead wire 14). In some embodiments, the defined portion extends over a portion of the length of the insulating member 76 or lead 14. In some other embodiments, the defined portion extends along the entire length of the insulating member 76. According to various embodiments, the protrusions 100 are arranged or formed to protrude linearly in the same direction.

  In some embodiments, the protrusion 100 is formed integrally with the electrically insulating member 76. In other embodiments, the protrusion 100 is structurally different from the electrically insulating member 76 and is separately attached to the electrically insulating member 76 during placement of the lead 14 into the patient's body. In various embodiments, the protrusion 100 is an insulating portion and is configured to insulate body tissue from stimuli caused by the at least one electrode 38. According to various exemplary embodiments, the protrusions can extend radially from the outer surface of the insulating member by a distance of about 1 mm to about 5 mm. As described above and illustrated in FIGS. 17A to 17B, the protrusion 100 is provided only on the outermost insulating member 76. However, in other embodiments, the protrusion 100 can be disposed on the inner insulating member (eg, 52 and / or 74), or on both the outer insulating member and the inner insulating member. In some embodiments of the invention, the outermost insulating member 76 includes an outer restraining mechanism 102 as shown in FIG. 17B. The restraining mechanism 102 is configured to lock the surrounding tissue to the window 78 of the insulating member 76 at an optimal position.

  18A-18D illustrate various embodiments of an insulating sheath comprising one or more protrusions 100 provided at the distal end portion of the lead. FIG. 18A shows three insulating sheaths 52, 74, 76 disposed inside each other. 18B to 18D respectively show the insulating members 52, 74, and 76 individually. As shown in FIGS. 18B to 18D, each insulating member 52, 74, 76 includes a protrusion 100. In some embodiments, for example, the implantable lead 14 is positioned such that the electrically insulating members (eg, 52, 74, and 76) include an inner insulating member 74 and an outer insulating member 76. The inner insulating member 74 includes the protrusion 100, and is configured so that the protrusion 100 is configured to extend from the inner insulating member 74 through the section of the outer insulating member 76 and beyond the outer surface of the insulating member 76. An insulating member 76 includes a window or compartment. Inner insulating member 74 and outer insulating member 76 are configured to rotate relative to a defined angle determined by the dimensions of the spatial compartment. The dimensions of the spatial compartment are further configured to limit exposure of at least one electrode 38 through at least one window 78. According to various exemplary embodiments, the window or compartment is dimensioned to allow the protrusion 100 to rotate at an angle of about 10 to about 150 degrees.

  In some other embodiments, for example, the implantable lead 14 is arranged such that the inner insulating member is the first inner insulating member 74, and the implantable lead 14 is the second inner insulating member. And a second inner insulating member 52 comprising a protrusion 100, a first inner insulating member 74 comprising a window or compartment, and the protrusion 100 extending from the second inner insulating member 52. It is configured to extend through the space section of the first inner insulating member 74 and the second space section of the outer insulating member 76, and this second space section is different from the space section of the inner insulating member 74. . FIG. 18A illustrates one embodiment, for example, where each protrusion 100 extends radially outward through a corresponding window in the covering sheath. Thus, as shown, in a fully assembled structure in which the respective insulating members 52, 74, 76 are disposed inside each other, each protrusion 100 extends outside the outer insulating sheath 76. I'm out.

  FIGS. 19A-19B each illustrate a perspective view and a cross-sectional view of an embodiment of a distal end portion of a lead wire 14 that includes an insulating member 52 having one or more protrusions 100. In some embodiments, as shown, the protrusion 100 has a non-circular or asymmetric cross section. As shown in FIG. 19A, the insulating sheath 52 includes a plurality of separate protrusions 100, and each protrusion 100 is generally aligned with the electrode 38 provided on the lead body 50. With such a configuration, each protrusion 100 can bring the corresponding electrode 38 closer to the target site. According to other embodiments, the sheath may include a greater or lesser number of protrusions than the corresponding electrode 38 of the lead body 50. As shown in FIG. 19B, the protrusion 100 can be disposed on a portion of the insulating sheath generally opposite the location of the exposure window adapted to electrically expose the electrode portion 38. . In this way, the protrusion 100 can function to bring the exposure window (and thus the electrode 38) closer to the target tissue and away from the surrounding tissue. According to various embodiments, the protrusion 100 is circumferential around a portion of the insulating sheath so as to extend over an angle of about 10 to about 180 degrees (shown as angle “θ” in FIG. 19B). Can extend in the direction. According to an exemplary embodiment, the protrusion 100 extends in an angular range of about 25 to about 120 degrees.

  FIG. 20 is a flowchart illustrating a method 400 for providing electrical stimulation to a tissue site. As shown, the method 400 includes disposing an electrically insulating member relative to a lead comprising at least one electrode, the insulating member being configured to expose at least a portion of the electrode. Defined at least one window (block 410). As described above, the insulating member further includes a protrusion that is linearly disposed on the defined portion thereof. The method further includes adjusting the degree of exposure of the electrode to the target tissue by adjusting at least one of a radial dimension and a longitudinal dimension of the at least one window, according to various embodiments. Including. In various embodiments, the insulating member is adjusted such that at least one window faces a target tissue site (eg, the vagus nerve) where stimulation is desired (block 420). The user (eg, a physician) can then advance the lead and insulation (together or separately) to a location near the target site. Once the window is positioned near the target tissue site and the degree of electrode exposure has been adjusted, the position of the protrusion is adjusted by rotating at least one insulating member (block 430). The position of the protrusion is adjusted such that the distance between the at least one electrode and the first surrounding tissue, eg, an irrelevant structure, is greater than the distance between the at least one electrode and the target tissue. Once the position of the protrusion is adjusted, the target tissue site is stimulated with at least one electrode (block 440). According to various embodiments, the lead body is then rotated to optimize alignment with the window of the electrode structure (i.e., the electrode extending only in a circumferentially limited segment of the lead body). To do. According to various embodiments, the method further includes detecting electrical activity at one or both of the desired target tissue site and the surrounding (ie unrelated) tissue site upon delivery of the stimulation by the electrode. The physician then further adjusts the spacing of the electrodes relative to these sites by further rotation of the lead body (and spacer member) based on the stimulation detected at one or both of the target tissue site and the unrelated tissue site. Can do. This operation can be repeated one or several times until the desired degree of electrical stimulation is detected at one or both of the target tissue site and the surrounding tissue site.

  FIG. 21A is a perspective view of an implantable lead 14 used in an implantable system, eg, CRM system 10 or implantable nerve stimulation system 110, according to various embodiments. As shown, lead 14 has a lead body 50 (having a longitudinal axis or centerline 106) and one coupled at various locations along the length of the lead body. The above spacer member 104 (having a longitudinal axis or center line 103) is provided. In various embodiments, the spacer member 104 can be rotationally coupled to the lead body such that the rotational motion of the lead body is a corresponding rotational motion of the spacer member. As shown in FIG. 21A, the member 104 is configured such that the cross-section has a radius that gradually increases in the circumferential direction. According to another embodiment, member 104 is circular in cross section. In other embodiments, the member 104 has a cross-sectional shape (eg, see FIGS. 21A and 21B) with a gradually increasing radius in the circumferential direction (eg, see FIGS. 21A and 21B), an oval shape (eg, see FIG. 22), or a tapered shape. It can have a shape (see, eg, FIGS. 23A, 23B, and 19C).

  The lead wire body 50 includes one or more electrodes 38 disposed at various locations along the length of the lead wire body. These electrodes 38 are coupled to the pulse generator of the CRM system 10 or neural stimulation system 110, which can stimulate or detect the target tissue. As further shown, the longitudinal axis 106 of the lead body 50 is offset from the centerline 103 of the member 104 by a distance 108. This offset distance 108 between the longitudinal centerline of the member 104 and the longitudinal centerline of the lead body 50 allows the user (eg, a physician) to target the target tissue site 111 ( For example, the position with respect to the vagus nerve) can be adjusted by rotating the lead wire body 50. In particular, the member 104 can function to move the electrode 38 of the lead body 50 closer to the target tissue site 11 or away from an undesirable site 113 (eg, muscle). By adjusting the radial position of the lead wire body (and thus the radial position of the member 104), the user can adjust the spacing between the electrode and the tissue site. According to various embodiments, the lead body has a diameter of about 1 mm to about 4 mm (eg, about 2.5 mm) and the distance 108 is about 1 mm to about 4 mm. In one exemplary embodiment, the lead body has a diameter of about 2 mm, the offset is about 2 mm, and the outer diameter of member 104 is about 8 mm. This embodiment allows the user to adjust the spacing from the tissue site in the range of about 1 mm to about 7 mm.

  As shown in FIG. 21A, the member 104 comprises three separate members each coupled separately to the lead body 50. In various embodiments, the member 104 can be located at a location corresponding to one or more electrodes 38. In other embodiments, the member 104 can be placed in other locations useful for controlling the spacing relative to the tissue site. In some embodiments, the geometric shape of each member 104 is the same (or substantially the same), and in other embodiments, one or more members 104 have different shapes. Further, in embodiments having multiple separate members 104, the spatial distance between the members may be the same or different. In other embodiments, as shown in FIG. 21B, member 104 is a single structure or a continuous structure that extends along a desired portion of the lead body. This continuous segment may comprise an optional window or electropermeable surface for exposing the electrode 38. Alternatively, the continuous segment can be placed or placed adjacent to one or more electrodes 38. According to various embodiments, the continuous member 104 has a length (ie, a dimension along the longitudinal axis of the lead body) of about 1 mm to about 10 mm. According to some embodiments, member 104 has a length of about 2 mm to about 5 mm.

  FIG. 21C is a cross-sectional view of an implantable lead 14 through member 104, according to various exemplary embodiments. As shown in the figure, the member 104 has a radius (r) extending from the center point to the outer periphery, and this radius (r) continuously increases as the angle θ increases. According to various embodiments, the member 104 can have a conformal or logarithmic spiral cross-section (eg, nautilus). As shown in FIG. 21C, the member 104 of the lead wire 14 includes an electrode exposure window 119 disposed between the electrode 38 and the outer peripheral surface of the lead wire 14. In various embodiments, the window 119 can be an open area or a conductive or electrically transmissive area. The window 119 can be configured to allow electrical communication between a portion of the electrode 38 and adjacent body tissue. Various embodiments of such exposure windows are disclosed in co-pending US Provisional Patent Application No. 61 / 578,628, filed December 21, 2011, the entire disclosure of which is incorporated herein by reference. Yes.

  In some embodiments, the target tissue site 111 is the vagus nerve, and thus the member 104 is configured to adjust the distance between the vagus nerve and the at least one electrode 38. This distance can be adjusted by the rotation of the lead wire main body 50, and the lead wire main body 50 can be rotated in the range of 0 to 360 degrees. As the device rotates, the electrode 38 can approach the vagus nerve 111 and move away from the adjacent muscle 113, which helps to lower the capture threshold of the vagus nerve and increase the stimulation threshold of the adjacent muscle.

  FIG. 22 shows a cross-sectional view of an exemplary embodiment of an implantable lead 14 having a non-circular cross-section member 104. In particular, as shown, member 104 has a generally oval cross section. In such an embodiment, as shown, the longitudinal axis 106 of the lead wire body 50 is spaced a distance (d) from the outer peripheral surface of the lead wire 14. Further, as shown in FIG. 22, the lead wire main body 50 includes an electrode 38 (for example, a ring electrode) that extends substantially partly or entirely on the outer periphery of the lead wire main body 50. An electrode exposure window 119 disposed between the electrode 38 and the outer peripheral surface of the lead wire 14 is also shown. In various embodiments, the window 119 can be an open area or a conductive or electrically transmissive area. The window 119 can be configured to allow electrical communication between a portion of the electrode 38 and adjacent body tissue. Various embodiments of such exposure windows are disclosed in co-pending US Provisional Patent Application No. 61 / 578,628, filed December 21, 2011, the entire disclosure of which is incorporated herein by reference. Yes.

  Depending on the rotational position of the lead wire 14, the distance (d) from the longitudinal axis 106 to the target site (for example, the vagus nerve) varies. Accordingly, similarly, the distance between the electrode 38 and the target site is also different. With this configuration, a user (for example, a doctor) can change the distance between the exposed portion of the electrode 38 and the surrounding body tissue by rotating the lead wire 14. According to an alternative embodiment, the lead 14 does not comprise a structurally independent or separate member 104, but instead the lead body 50 has a generally oval cross section.

  FIGS. 23A-23B illustrate schematic views of exemplary embodiments of an implantable lead 14 used in an implantable system, eg, CRM system 10 or neural stimulation system 110, according to various embodiments. Yes. As shown in FIG. 23A, the lead 14 includes a lead body 50 and a plurality of spaced apart members 104 at various positions along the length of the lead body. As illustrated, the lead body 50 includes a plurality (eg, four) of electrodes 38 spaced along the length thereof. The member 104 is rotationally coupled to the lead wire main body 50, so that when the lead wire main body rotates, the member 104 rotates correspondingly. Also, the member 104 is coupled to the lead body at a position between the electrodes 38, thereby maintaining exposure of the electrodes to adjacent body tissue. As further shown, the diameter of member 104 increases from the top to the bottom of FIG. 23A. These larger diameters allow different spacings between the various electrodes and surrounding body tissue. The dimensions of each member 104 can be selected to optimize the spacing of a given anatomical region of the body. According to various exemplary embodiments, the smallest member 104 has a diameter of about 2 to about 5 mm. Each subsequent member 104 is then about 20 to about 70% larger in diameter than the immediately preceding member 104. In some embodiments, the diameter of the member 104 can be selected to form an effectively tapered shape along the length of the lead 14. Other dimensional configurations are possible.

  In other embodiments, the tapered shape can be formed continuously as illustrated in FIG. 23B. This tapered shape / outline can be designed to be tapered or divergent to accommodate non-uniform anatomical stimulation of the target tissue / site 111. 23A and 23B illustrate examples of a tapered non-circular cross-sectional shape that is a tapered or divergent shape from one position of the lead wire body 50 to another position.

  FIGS. 24A-24C illustrate other exemplary profiles of implantable lead 14. As shown, in these embodiments, the overall lead diameter increases and decreases at various locations along the length of the lead to correspond to the desired stimulation (or detection) tissue site. doing. Similarly, the exact dimensions will depend on the particular anatomical location that is stimulated. FIG. 24A tapers from the first end of the lead body 50 at a constant distance along its length and then dips toward the other end of the lead body 50 having a tapered width. Figure 3 shows a 3D surface plot of a non-circular cross-sectional segment. In such an embodiment, the tapered and divergent portions of member 104 may be symmetric or asymmetric in shape. In other embodiments, the member 104 can have several such tapered and divergent portions, wherein these tapered and divergent portions can be of different types, repeating one after another alternately or randomly. Form a shape. In other embodiments, the tapered shape of the member 104 can be determined based on customer requirements and the shape of the target tissue, or stimulation requirements at variable distances along the target tissue 111. 24B and 24C show other exemplary profiles drawn in a Cartesian coordinate system. The major axis represents the height of the non-circular cross-sectional segment at a particular point, and the minor axis represents the straight length of the non-circular cross-sectional segment at the particular point. In each of the embodiments illustrated in FIGS. 24A-24C, the lead 14 includes one or more electrodes located at a distance from its longitudinal centerline. Thus, the distance between the electrode and the target tissue 111 (or other unrelated tissue 113) can be changed by rotation of the lead body. However, in these embodiments, the distance between any electrode and surrounding body tissue will vary based on the profile of member 104 along the length of lead 14.

  FIG. 25 is a flowchart illustrating a method 500 for supplying electrical stimulation to a target tissue site and minimizing / reducing stimulation to an irrelevant tissue site using any of the various described embodiments. The method 500 includes implanting the implantable lead 14 into a patient (block 510). In some embodiments, the target tissue site is the vagus nerve and the irrelevant tissue site is the muscle near the vagus nerve. In various other embodiments, the target stimulation site and unrelated tissue sites can be other nerve, tissue, muscle, or body sites. The method 500 adjusts the physical space between the at least one electrode of the lead and the target tissue site by rotating the lead body and rotating a spatial member rotationally coupled to the lead body. A further step is included (block 520). Adjusting the rotation of the lead wire body causes the spacer member to rotate correspondingly, thereby causing an offset between the first center line of the lead wire body and the second center line of the spacer member to at least one from the target tissue site. The distance between the two electrodes is changed. Based on the requirements and the anatomy of the target tissue site, the rotation adjustment associated with the various shaped members places the electrode at the appropriate distance from the target tissue site and at the same time the distance between the irrelevant tissue and the electrode Can be adjusted. The method further includes stimulating the target tissue site (or body tissue near the target tissue site) with at least one electrode (block 530). According to various embodiments, the method further includes detecting electrical activity of one or both of the desired target tissue site and the unrelated tissue site when the stimulus is delivered by the electrode. Then, based on the stimulation detected at one or both of the target tissue site and the unrelated tissue site, the physician further adjusts the spacing of the electrodes relative to these sites by further rotation of the lead body (and spacer member) Can do. This operation can be repeated one or more times until the desired degree of electrical stimulation is detected at one or both of the target tissue site and the unrelated tissue site.

  In Example 39, the implantable lead is a lead body comprising a proximal end, a distal end, and at least one electrode extending circumferentially around at least a portion of the lead body. A wire body and a sheath member extending axially relative to a portion of the lead body between the proximal end and the distal end, the sheath member defining an at least one window. It is formed from an insulating member. In this example, the electrical insulation member is configured to rotate about the lead body so that, in the first radial position, the first portion of the at least one electrode has at least one window. And the second portion of the at least one electrode is covered by the electrically insulating member so that each of the lead wire body and the electrically insulating member fixes the electrically insulating member to the lead wire body in a desired orientation. The corresponding mechanism is provided.

Example 40 is the implantable lead of Example 39, wherein the at least one window is a conductive section of an electrically insulating member.
Example 41 is the implantable lead of Example 39 or Example 40, wherein the at least one electrode extends 360 degrees around the lead body.

  Example 42 is such that at least one electrode covers a first radial quadrant of the lead body corresponding to a radial surface extending about 0-90 degrees around the lead body. A first electrode disposed around the lead wire body and a second radial direction of the lead wire body corresponding to a radial surface extending about 90-180 degrees around the lead wire body A second electrode disposed around the lead wire body so as to cover the quadrant and a lead wire body corresponding to a radial surface extending about 180-270 degrees around the lead wire body; A third electrode disposed around the lead wire body so as to cover the third radial quadrant, and a radial surface extending about 270 to 360 degrees around the lead wire body Arranged around the lead wire body to cover the fourth radial quadrant of the lead wire body corresponding to Comprising a fourth electrode, a is any implantable lead of Example 39 to Example 41.

  Example 43 is such that at least one electrode covers a first radial quadrant of the lead body corresponding to a radial surface extending about 0-90 degrees around the lead body. A first electrode disposed around the lead wire body and a second radial direction of the lead wire body corresponding to a radial surface extending about 45-135 degrees around the lead wire body A second electrode disposed around the lead wire body to cover the quadrant and a lead wire body corresponding to a radial surface extending about 90-180 degrees around the lead wire body A third electrode disposed around the lead wire body so as to cover the third radial quadrant, and a radial surface extending about 135 to 225 degrees around the lead wire body Is arranged around the lead wire body so as to cover the fourth radial quadrant of the lead wire body corresponding to And comprising a fourth electrode, a is any implantable lead of Example 39 to Example 42.

  Example 44 includes first and second electrodes with at least one electrode extending around the lead body at a radial position corresponding to 0-90 degrees, and a radial position corresponding to 90-180 degrees. 45 is an implantable lead according to any of Examples 39 to 43, comprising third and fourth electrodes extending around the lead body in FIG.

  Example 45 is the implantable lead of any of Examples 39-44, further comprising an axial locking member configured to secure the sheath in place with respect to the lead body. .

Example 46 is the implantable lead of any of Examples 39-45, wherein the axial locking member is a protrusion coupled to the lead body.
Example 47 is the implantable lead of any of Examples 39-46, wherein the protrusion is configured to engage the recess of the sheath.

  Example 48 further includes a radial locking member configured to secure the sheath in place relative to the lead body at one of a plurality of radial positions around the lead body. ~ Implantable lead of any of Example 47.

  Example 49 is the implantable lead of any of Examples 39-48, further comprising at least one stop member configured to limit axial movement of the sheath relative to the lead body. .

Example 50 is the implantable lead of any of Examples 39-49, wherein the at least one stop member is a ring provided on the lead body.
Example 51 is the implantable lead of any of Examples 39-50, wherein the at least one window has a generally helical shape.

Example 52 is the implantable lead of any of Examples 39-51, wherein the at least one window comprises a spiral window having at least two non-parallel spirals.
Example 53 is an implantable according to any of Examples 39-52, wherein the sleeve comprises a groove configured to receive a suture to secure the position of the sheath relative to the lead body. Lead wire.

  Example 54 further includes a second sheath extending axially over a portion of the first sheath, wherein the second sheath defines a second window. 56 is the implantable lead of any of Example 53.

  Example 55 is a method of implanting a medical lead wire into a tissue site, and this method is a step of preparing a lead wire body, the lead wire body comprising at least a proximal end portion, a distal end portion, and a lead wire body. Comprising at least one electrode extending circumferentially around a portion, the lead body comprising an insulating sheath disposed at the tip, the insulating sheath comprising at least one exposed window; Adjusting the step and at least one of a radial position and a longitudinal position of the insulating sheath relative to the at least one electrode, thereby exposing a desired portion of the electrode and fixing the position of the insulating sheath relative to the electrode Including the steps of:

Example 56 is the method of example 55, wherein the at least one window is an electrically transmissive window.
Example 57 is a lead wire main body, and includes at least a base end portion, a tip end portion, a first screw portion between the base end portion and the tip end portion, and at least substantially extending around the lead wire main body. An implantable medical lead comprising: a lead body having one electrode; and an electrically insulating member extending axially over a portion of the lead body between the proximal and distal ends. . The electrically insulating member defines at least one window and is configured to be rotatable about the lead body so that, in the first radial position, the first portion of the at least one electrode is at least Exposed through one window and a second portion of at least one electrode is covered by an electrically insulating member. The electrical insulating member further includes a second screw portion. The first threaded portion is configured to engage with the second threaded portion so as to perform both axial and radial adjustments of the electrical insulation member relative to the lead body.

  In Example 58, the length of the first threaded portion and the length of the second threaded portion are linearly moved with respect to the lead wire body of the electrically insulating member, and at least one window of at least one electrode. Fig. 58 is an implantable lead of Example 57 that controls the degree of exposure.

  Various changes and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, although the embodiments described above describe specific features, the scope of the invention includes embodiments having different combinations of features and embodiments that do not include all of the features described. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims and all equivalents thereof.

Claims (20)

An implantable medical lead for stimulating or detecting target tissue and minimizing stimulation of surrounding tissue,
A lead wire body having a proximal end, a tip, and at least one electrode extending circumferentially around at least a portion of the lead wire body;
An insulating sheath disposed over at least a portion of the distal end of the lead body, the sheath being configured to rotate about the lead body, and the at least one electrode to the target tissue An insulating sheath having an exposed window adapted to be electrically exposed to
At least one protrusion extending radially outward from a portion of the insulating sheath at a position generally opposite to the exposure window, wherein the insulating sheath rotates around the lead body. At least one electrode is adapted to be closer to the target tissue, so that the distance between the at least one electrode and the target tissue is greater than the corresponding distance between the at least one electrode and the surrounding tissue. An implantable medical lead comprising at least one protrusion that is also shorter. The implantable medical lead according to claim 1, wherein the protrusion is formed integrally with the insulating sheath. The insulating sheath includes an inner insulating member and an outer insulating member having a compartment, and the protrusion is disposed on the inner insulating member and extends at least partially through the compartment. The implantable medical lead according to claim 1, wherein the implantable medical lead. 4. The implantable medical lead according to claim 3, wherein rotation of the inner insulating member relative to the outer insulating member is limited by contact between the protrusion and an edge of the compartment. The lead wire body includes a plurality of electrodes, the insulating sheath includes a plurality of protrusions, and each protrusion is arranged at a position along the length of the insulating sheath aligned with the position of the corresponding electrode. The implantable medical lead according to claim 1, wherein the implantable medical lead is provided. The implantable medical lead according to claim 1, wherein the protrusion extends circumferentially around the insulating sheath over an angle of about 25 to about 120 degrees. The implantable medical lead according to claim 1, wherein the protrusion is a separate structure coupled to the insulating sheath and is configured for attachment upon delivery of the lead. . The implantable medical lead according to claim 1, wherein the protrusion is formed from an insulating material and is configured to protect the surrounding tissue from electrical stimulation delivered by the at least one electrode. line. The implantable medical lead according to claim 1, wherein the exposed window is selected from the group consisting of a physical window and an electrically permeable window. The implantable medical lead according to claim 1, wherein the protrusion extends radially outward from the insulating sheath at a distance of about 1 mm to about 5 mm. An implantable medical lead for stimulating or detecting target tissue and minimizing stimulation of surrounding tissue,
A lead wire body having a plurality of spaced apart electrodes extending circumferentially around at least a portion of the base end, tip, and lead wire body; and
An insulating sheath disposed on at least a part of a distal end portion of the lead wire main body, configured to rotate around the lead wire main body, and at least one of the plurality of electrodes is connected to the lead wire main body; An insulating sheath having a plurality of exposure windows adapted to be electrically exposed to the target tissue;
A plurality of insulating protrusions extending radially outward from a portion of the insulating sheath at a position generally opposite to the corresponding exposed window, wherein each of the protruding portions is the insulating sheath of the lead wire body. Adapted to bring the corresponding exposure window closer to the target tissue when rotating around, so that the distance between the corresponding exposure window and the target tissue is the distance between the corresponding exposure window and the surrounding tissue. An implantable medical lead comprising a plurality of insulating protrusions that are shorter than corresponding distances therebetween. 12. The implantable medical lead according to claim 11, wherein each of the plurality of insulating protrusions extends circumferentially around the insulating sheath over an angle of about 25 to about 120 degrees. The implantable medical lead according to claim 11, wherein each of the exposed windows is selected from the group consisting of a physical window and an electrically permeable window. The implantable medical lead according to claim 11, wherein the protrusion is integrally formed with the insulating sheath. The implantable medical lead according to claim 11, wherein the plurality of insulating protrusions are configured to protect the surrounding tissue from electrical stimulation delivered by the plurality of spaced apart electrodes. The insulating sheath includes an inner insulating member and an outer insulating member having a compartment, and the protrusion is disposed on the inner insulating member and extends at least partially through the compartment. The implantable medical lead according to claim 11, wherein the implantable medical lead. A method of providing electrical stimulation to a target tissue and minimizing electrical stimulation of surrounding tissue,
Providing a lead wire body, the lead wire body having a proximal end, a distal end, and at least one electrode extending circumferentially around at least a portion of the lead wire body, wherein the lead An exposure sheath having an insulating sheath disposed over at least a portion of the distal end of the wire body, wherein the insulating sheath is adapted to electrically expose the at least one electrode to the target tissue; The insulating sheath further includes at least one projecting portion extending radially outward from a portion of the insulating sheath at a position generally opposite to the exposed window, the projecting portion comprising: Adapted to bring the at least one electrode closer to the target tissue as the insulating sheath rotates about the lead body;
Advancing the distal end of the lead body and disposing the at least one electrode at a location near the target tissue;
Rotating the insulating sheath to adjust the position of the protrusion to move the at least one electrode closer to the target tissue and away from the surrounding tissue. The method of claim 17, further comprising stimulating the target tissue with the at least one electrode. The method of claim 17, further comprising attaching the protrusion to the insulating sheath prior to advancing the distal end of the lead body to a position proximate to the target tissue. The target tissue is a vagus nerve, the surrounding tissue includes a muscle adjacent to the vagus nerve, and the rotating step causes the at least one electrode to approach the vagus nerve and adjacent to the vagus nerve. The method of claim 17, wherein the method moves away from the muscular muscle.